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1.  Phase I feasibility study of intraperitoneal cisplatin and intravenous paclitaxel followed by intraperitoneal paclitaxel in untreated ovarian, fallopian tube, and primary peritoneal carcinoma: A Gynecologic Oncology Group Study 
Gynecologic oncology  2011;123(2):182-186.
Intraperitoneal chemotherapy has shown a survival advantage over intravenous chemotherapy for women with newly diagnosed optimally debulked epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. However, significant toxicity has limited its acceptance. In an effort to reduce toxicity, the Gynecologic Oncology Group conducted a Phase I study to evaluate the feasibility of day 1 intravenous (IV) paclitaxel and intraperitoneal (IP) cisplatin followed by day 8 IP paclitaxel on an every 21-day cycle.
Patients with Stage IIB-IV epithelial ovarian, fallopian tube, primary peritoneal carcinomas or carcinosarcoma received paclitaxel 135 mg/m2 IV over 3 hours followed by cisplatin 75 mg/m2 IP on day 1 and paclitaxel 60 mg/m2 IP on day 8 of a 21 day cycle with 6 cycles planned. Dose-limiting toxicity (DLT) was defined as febrile neutropenia or dose-delay of greater than 2 weeks due to failure to recover counts, or Grade 3-5 non-hematologic toxicity occurring within the first 4 cycles of treatment.
Twenty of 23 patients enrolled were evaluable and nineteen (95%) completed all six cycles of therapy. Three patients experienced a DLT consisting of infection with normal absolute neutrophil count, grade 3 hyperglycemia, and grade 4 abdominal pain.
This modified IP regimen which administers both IV paclitaxel and IP cisplatin on day one, followed by IP paclitaxel on day eight, of a twenty-one day cycle appears feasible and is an attractive alternative to the intraperitoneal treatment regimen administered in GOG-0172.
PMCID: PMC3201726  PMID: 21820161
Ovarian cancer; intraperitoneal chemotherapy; cisplatin; paclitaxel; phase I trial
2.  Endometrial stromal sarcoma metastasis to the lumbar spine and sphenoid bone 
Rare Tumors  2011;3(3):e27.
Endometrial stromal sarcoma (ESS) is typically associated with metastasis to the abdomen, pelvis, and lung. We found three case reports of ESS metastasis to the bone (two to the thoracic spine, and one to the parietal bone). Our objective is to review the literature on ESS spinal and intracranial metastases and, report the first case of ESS metastatic to the lumbar paraspinal region and sphenoid bone. A 53-year-old female with ESS status-post radiation, chemotherapy, and pelvic exenteration surgery presented with right hip weakness, back pain, and radicular leg pain that were explained by chemotherapy-induced neuropathy, radiation-induced lumbosacral plexopathy, and femoral nerve and obturator nerve injury during pelvic exenteration surgery. During routine positron emission tomography, we found metastasis to the L3 lumbar spinal region. L3 laminectomy and subtotal resection of the mass was performed with tumor residual in the neuroforamina and pedicles. One month later, magnetic resonance imaging (MRI) performed for persistent headaches revealed a large lesion in the sphenoid bone that was biopsied transsphenoidally with the same diagnosis, but no further surgery was performed. She is intolerant of chemotherapy and currently undergoing whole brain radiation. Delay in the diagnosis and management of lumbar paraspinal and sphenoid bone metastasis of ESS likely occurred because of the uniqueness of the location and aggressiveness of ESS metastasis. Health care providers should be aware of potentially aggressive metastasis of ESS to bone, in particular the unusual locations of the lumbar paraspinal region and sphenoid bone.
PMCID: PMC3208414  PMID: 22066034
endometrial stromal sarcoma; uterine sarcoma; lumbar spine; sphenoid bone; bone metastasis.
3.  Sunitinib Malate in the treatment of recurrent or persistent uterine leiomyosarcoma: A Gynecologic Oncology Group phase II study 
Gynecologic oncology  2009;115(3):460-465.
New agents are needed for patients with metastatic uterine leiomyosarcoma who progress after treatment with doxorubicin or gemcitabine-docetaxel. Agents targeting tumor vasculature have potential for activity in leiomyosarcoma. We aimed to assess the activity of sunitinib in patients with recurrent uterine leiomyosarcoma who had received one or two prior therapies by determining the frequency of patients who survived progression-free for at least six months or who achieved objective tumor response. We also aimed to characterize the toxicity of sunitinib and to estimate time-to-progression.
Patients and Methods
Eligible patients with uterine leiomyosarcoma were treated with sunitinib 50 mg by mouth daily for four weeks, with two weeks rest. Tumor response and progression-free status were assessed every six weeks.
Twenty-three of 25 patients enrolled were evaluable for efficacy (two wrong histologies). The median number of cycles was one. Two of 23 patients achieved a partial response (8.7%, 90% two-sided, binomial confidence interval (CI) 1.6 –24.9%). Four patients remained progression-free at six months (17.4%, 90% two-sided, binomial confidence interval 6.2–35.5%). Toxicities included: grade 3 neutropenia (17.4%); grade 3 thrombocytopenia (13%); grade 3 anemia (17.4%); grade 3–4 lymphopenia (8.7%); grade 3–4 fatigue (30%); grade 3 vomiting/diarrhea (21.7%); skin rash/hand-foot syndrome, grade 2 (13%), grade 3 (4.3%); hypertension, grade 2 (39%), grade 3 (4.3%); grade 2 decrease in cardiac ejection fraction (4.3%), and grade 3 thrombosis (4.3%). Median progression-free survival was 1.5 months.
Sunitinib fails to achieve sufficient objective response or sustained disease stabilization as second- or third-line treatment for uterine leiomyosarcoma.
PMCID: PMC2783261  PMID: 19811811
uterine leiomyosarcoma; sunitinib

Results 1-3 (3)